Grace Fine Chemical Manufacturing Services operates a state-of-the-art pharmaceutical manufacturing facility in Tyrone, Pennsylvania, serving as a leading contract development and manufacturing organization with over 40 years of industry expertise. The company specializes in custom Active Pharmaceutical Ingredient development, generic API manufacturing, and regulatory starting materials synthesis, maintaining 15 current Drug Master Files and operating under stringent cGMP compliance standards.
The Tyrone facility features more than 80,000 gallons of reactor capacity, advanced R&D laboratories, pilot plant capabilities, and full-scale manufacturing operations designed to handle complex molecular synthesis projects. Grace FCMS excels in specialized chemistries including chiral molecules, custom boronic acids, amino acids with protecting groups, and solution phase peptide synthesis, utilizing advanced catalysis techniques and cryogenic reaction capabilities.
With integrated quality management systems aligned to FDA and ICH requirements, Grace FCMS provides comprehensive services from early development through commercial manufacturing, supporting scale ranges from one kilogram to multiple metric tons. The facility maintains exceptional safety standards, holding OSHA Voluntary Protection Program STAR status for 14 consecutive years since 2008.
Grace FCMS delivers value through transparent communication, collaborative customer partnerships, and efficient development methodologies across pharmaceutical, nutraceutical, and fine chemical sectors. The company operates two fully integrated North American manufacturing sites, providing customers with robust supply chain security and comprehensive technical support throughout the entire product lifecycle.
Specialties: Custom API developmentCommercial API manufacturingRegistered starting materials +1 more
Processes: API ManufacturingContract Manufacturing +1 more